Benitec Biopharma Releases Full Year 2022 Financial Results and Provides Operational Update
September 02 2022 - 8:00AM
Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “the Company”),
a development-stage, gene therapy-focused, biotechnology company
developing novel genetic medicines based on its proprietary
DNA-directed RNA interference ("ddRNAi") platform, today announced
financial results for its Fiscal Year ended June 30, 2022. The
Company has filed its annual report on Form 10-K for the quarter
ended June 30, 2022, with the U.S. Securities and Exchange
Commission.
“We continue to move closer to the initiation of
the clinical evaluation of BB-301,” said Jerel A. Banks, M.D.,
Ph.D., Executive Chairman and Chief Executive Officer of Benitec
Biopharma. “The Benitec team remains committed to improving the
lives of patients suffering from Oculopharyngeal Muscular
Dystrophy.”
Operational Updates
The key milestones related to the development of
BB-301 for Oculopharyngeal Muscular Dystrophy (OPMD) by the
Company, along with other corporate updates, are outlined
below:
BB-301 Clinical Development Program
Overview:
- The BB-301 clinical development program will be conducted in
France, Canada, and the United States, and the primary elements of
the clinical development plan are summarized below.
- The clinical development plan will begin in 2022 and comprise
approximately 76 weeks of follow-up:
- 6-month pre-treatment observation periods for the evaluation of
baseline disposition and natural history of OPMD-derived dysphagia
(swallowing impairment) in each study participant.
- 1-day of BB-301 dosing to initiate participation in the Phase
1b/2a single-arm, open-label, sequential, dose-escalation cohort
study.
- 52-weeks of post-dosing follow-up for conclusive evaluation of
the primary and secondary endpoints of the Phase 1b/2a BB-301
treatment study.
- The OPMD Natural History (NH) Study (i.e., the 6-month
pre-treatment observation period) will facilitate the
characterization of OPMD patient disposition at baseline and assess
subsequent rates of progression of dysphagia via the use of the
following quantitative radiographic measures (i.e.,
videofluoroscopic swallowing studies or “VFSS”), with the VFSS
outlined below collectively providing objective assessments of
global swallowing function and the function of the pharyngeal
constrictor muscles (i.e., the muscles whose functional
deterioration drives disease progression in OPMD):
- Total Pharyngeal Residue %(C2-4)2
- Pharyngeal Area at Maximum Constriction (PhAMPC)
- Dynamic Imaging Grade of Swallowing Toxicity Scale
(DIGEST)
- Vallecular Residue %(C2-4)2, Pyriform Sinus Residue %(C2-4)2,
and Other Pharyngeal Residue %(C2-4)2
- Normalized Residue Ratio Scale (NRRSv, NRRSp)
- Pharyngeal Construction Ratio (PCR)
- The NH study will also employ clinical measures of global
swallowing capacity and oropharyngeal dysphagia, along with two
distinct patient-reported outcome instruments targeting the
assessment of oropharyngeal dysphagia.
- Upon the achievement of 6-months of follow-up in the NH Study,
participants will be eligible for enrollment onto the BB-301 Phase
1b/2a treatment study.
- BB-301 Phase 1b/2a Treatment Study:
- This first-in-human (FIH) study will be a Phase 1b/2a,
open-label, dose-escalation study to evaluate the safety and
clinical activity of intramuscular doses of BB-301 administered to
subjects with OPMD.
- Upon rollover onto the Phase 1b/2a BB-301 treatment study, the
follow-up of OPMD study participants will continue for 52
weeks.
- The primary endpoints of the FIH study will be safety and
tolerability, with secondary endpoints comprising quantitative
radiographic measures of global swallowing function and pharyngeal
constrictor muscle function (i.e., VFSS) as well as clinical
assessments (all of which will be equivalent to those employed for
the NH study). These endpoints will be evaluated during each 90-day
period following BB-301 intramuscular injection (Day 1).
- The natural history of dysphagia observed for each OPMD study
participant, as characterized by the VFSS and clinical swallowing
assessments carried out during the NH Study, will serve as the
baseline for comparative assessment of safety and efficacy of
BB-301 upon rollover from the NH Study onto the Treatment
Study.
Operational and Regulatory Updates for
the Clinical Development Program:
France:
- In the Second Calendar Quarter 2022, the NH Study Protocol, the
Patient Informed Consent Form, the patient-facing documents and the
physician-facing documents were completed; primary clinical study
sites were formally qualified; Principal Investigators and
Sub-Investigators were identified at the clinical study sites; the
core VFSS site was selected and qualified; and the central reader
for the VFSS data was selected.
- Upon completion of these operational milestones, a formal
submission was made to the Central Ethics Committee (CEC) in
France.
- In the Third Calendar Quarter 2022, Benitec received feedback
from the CEC advising minor changes to the text of the Patient
Informed Consent form (ICF).
- The suggested updates were incorporated into the ICF, and the
formal re-submission process for CEC final review has been
completed.
- Approval of the updated ICF, and the overall NH Study trial
package, by the CEC allows for clinical study site activation and
OPMD patient screening and enrollment to begin in France.
- The final CEC decision is expected in October 2022 (allowing
for NH Study screening visits and patient enrollment to begin in
the Fourth Calendar Quarter 2022).
North America:
- Formal submission of the
comprehensive NH Study trial package to the Institutional Review
Board (IRB) at the lead clinical study site in the United States
was completed in August 2022.
- Approval of the overall NH Study trial package by the IRB
allows for clinical study site activation and OPMD patient
screening and enrollment to begin in the United States.
- The IRB decision is expected in October 2022 (allowing for NH
Study screening visits and patient enrollment to begin in the
Fourth Calendar Quarter 2022).
- Benitec plans to complete the
formal submission of the comprehensive NH Study trial package to
the Research Ethics Board (REB) for the lead clinical site in
Canada in the Fourth Calendar Quarter 2022.
- Approval of the overall NH Study trial package by the REB
allows for clinical study site activation and OPMD patient
screening and enrollment to begin in Canada.
BB-301 Phase 1b/2a Regulatory Updates:
- Clinical Trial Application (CTA)
and Investigational New Drug (IND) filings are anticipated in the
First Calendar Quarter 2023.
- CTA and IND filings are required to
initiate the BB-301 Phase 1b/2a Treatment Study in France, Canada,
and the United States.
- The first NH Study subject is
anticipated to be eligible for BB-301 administration in the Second
Calendar Quarter 2023 (following 6-months of NH Study enrollment
and follow-up and final confirmation of eligibility for the BB-301
Phase 1b/2a Treatment Study).
- Interim safety and efficacy data
for subjects enrolled onto the BB-301 Phase 1b/2a Treatment Study
are anticipated to become available for disclosure every 90-days
following BB-301 administration.
- In preclinical proof-of-concept
studies for BB-301, the OPMD disease phenotype was reversed at 14
weeks (i.e., approximately 90-days) after the administration of
BB-301 (with the strength of BB-301 injected muscles being restored
in the diseased animals and robust evidence of anatomical and
microscopic improvement of the BB-301 injected muscle tissues being
observed).
Financial Highlights
Full Year 2022 Financial Results
Total Revenues for the year ended June 30, 2022,
were $73 thousand compared to $59 thousand for the year ended June
30, 2021. The increase in revenues from customers is due to the
increase in licensing and royalty revenues in the current year.
Total Expenses for the year ended June 30, 2022,
were $17.9 million compared to $13.7 million for the year ended
June 30, 2021. For the year ended June 30, 2022, Benitec incurred
$9 thousand in royalties and license fees compared to $123 thousand
for the comparable year ended June 30, 2021. The change is
primarily due to a decrease in license fees. The Company incurred
$11.2 million of research and development expenses compared to $7
million for the comparable year ended June 30, 2021. The increase
in research and development expenses relates primarily to the OPMD
project. The Company concluded the BB-301 Regulatory Toxicology
Study and the Parallel Assay Method Development, Qualification, and
Validation project, and continued with the GMP Manufacturing
project.
General and administrative expenses were $6.6
million compared to $6.5 million for the year ended June 30,
2021.
The loss from operations for the fiscal year
ended June 30, 2022, was $18.2 million compared to a loss of $13.9
million for the year ended June 30, 2021. Net loss attributable to
shareholders for the year ended June 30, 2022, was $18.2 million,
or $2.23 per basic and diluted share, compared to a net loss of
$13.9 million, or $3.23 per basic and diluted share for the year
ended June 30, 2021. As of June 30, 2022, the Company had $4.1
million in cash and cash equivalents.
BENITEC
BIOPHARMA INC. |
Consolidated Balance
Sheets |
(in thousands,
except par value and share amounts) |
|
|
|
|
|
|
|
June 30, 2022 |
|
|
June 30, 2021 |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
4,062 |
|
|
$ |
19,769 |
|
Restricted Cash |
14 |
|
|
15 |
|
Trade and other receivables |
3 |
|
|
25 |
|
Prepaid and other assets |
741 |
|
|
799 |
|
Total current assets |
4,820 |
|
|
20,608 |
|
Property and equipment, net |
222 |
|
|
375 |
|
Deposits |
25 |
|
|
9 |
|
Other assets |
135 |
|
|
185 |
|
Right-of-use assets |
771 |
|
|
202 |
|
Total assets |
$ |
5,973 |
|
|
$ |
21,379 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Trade and other payables |
$ |
1,880 |
|
|
$ |
880 |
|
Accrued employee benefits |
400 |
|
|
276 |
|
Lease liabilities, current portion |
252 |
|
|
213 |
|
Total current liabilities |
2,532 |
|
|
1,369 |
|
Lease liabilities, less current portion |
559 |
|
|
— |
|
Total liabilities |
3,091 |
|
|
1,369 |
|
Commitments and contingencies (Note 12) |
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
Common stock, $0.0001 par value—40,000,000 shares authorized;
8,171,690 shares issued and outstanding at June 30, 2022 and
2021 |
1 |
|
|
1 |
|
Additional paid-in capital |
152,453 |
|
|
151,583 |
|
Accumulated deficit |
(148,327 |
) |
|
(130,119 |
) |
Accumulated other comprehensive loss |
(1,245 |
) |
|
(1,455 |
) |
Total stockholders’ equity |
2,882 |
|
|
20,010 |
|
Total liabilities and stockholders’ equity |
$ |
5,973 |
|
|
$ |
21,379 |
|
|
|
|
|
|
|
The accompanying
notes are an integral part of these consolidated financial
statements. |
BENITEC
BIOPHARMA INC. |
Consolidated
Statements of Operations and Comprehensive
Loss |
(in thousands,
except share and per share
amounts) |
|
|
Year Ended June 30, |
|
|
2022 |
|
|
2021 |
|
Revenue: |
|
|
|
|
|
Revenues from customers |
$ |
73 |
|
|
$ |
59 |
|
Operating
expenses |
|
|
|
|
|
Royalties and license fees |
9 |
|
|
123 |
|
Research and development |
11,272 |
|
|
7,020 |
|
General and administrative |
6,646 |
|
|
6,512 |
|
Total operating expenses |
17,927 |
|
|
13,655 |
|
Loss from operations |
(17,854 |
) |
|
(13,596 |
) |
Other income (loss): |
|
|
|
|
|
Foreign currency transaction loss |
(232 |
) |
|
(333 |
) |
Interest expense, net |
(32 |
) |
|
(6 |
) |
Other income (expense), net |
(79 |
) |
|
37 |
|
Unrealized gain (loss) on investment |
(11 |
) |
|
16 |
|
Total other loss, net |
(354 |
) |
|
(286 |
) |
Net loss |
$ |
(18,208 |
) |
|
$ |
(13,882 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
Unrealized foreign currency translation gain |
210 |
|
|
498 |
|
Total other comprehensive income |
210 |
|
|
498 |
|
Total comprehensive loss |
$ |
(17,998 |
) |
|
$ |
(13,384 |
) |
Net loss |
$ |
(18,208 |
) |
|
$ |
(13,882 |
) |
Net loss per share: |
|
|
|
|
|
Basic and diluted |
$ |
(2.23 |
) |
|
$ |
(3.23 |
) |
Weighted-average shares outstanding: |
|
|
|
|
|
Basic and diluted |
8,171,690 |
|
|
4,295,416 |
|
|
|
|
|
|
|
The accompanying
notes are an integral part of these consolidated financial
statements. |
About Benitec Biopharma
Inc.
Benitec Biopharma Inc. (“Benitec” or the
“Company”) is a development-stage biotechnology company focused on
the advancement of novel genetic medicines with headquarters in
Hayward, California. The proprietary platform, called DNA-directed
RNA interference, or ddRNAi, combines RNA interference, or RNAi,
with gene therapy to create medicines that facilitate sustained
silencing of disease-causing genes following a single
administration. The Company is developing ddRNAi-based therapeutics
for chronic and life-threatening human conditions including
Oculopharyngeal Muscular Dystrophy (OPMD). A comprehensive overview
of the Company can be found on Benitec’s website at
www.benitec.com.
Forward Looking Statements
Except for the historical information set forth
herein, the matters set forth in this press release include
forward-looking statements, including statements regarding
Benitec's plans to develop and commercialize its product
candidates, the timing of the initiation and completion of
pre-clinical and clinical trials, the timing of patient enrolment
and dosing in clinical trials, the timing of expected regulatory
filings, the clinical utility and potential attributes and benefits
of ddRNAi and Benitec's product candidates, potential future
out-licenses and collaborations, the intellectual property position
and the ability to procure additional sources of financing, and
other forward-looking statements.
These forward-looking statements are based on
the Company's current expectations and subject to risks and
uncertainties that may cause actual results to differ materially,
including unanticipated developments in and risks related to:
unanticipated delays; further research and development and the
results of clinical trials possibly being unsuccessful or
insufficient to meet applicable regulatory standards or warrant
continued development; the ability to enroll sufficient numbers of
subjects in clinical trials; determinations made by the FDA and
other governmental authorities; the Company's ability to protect
and enforce its patents and other intellectual property rights; the
Company's dependence on its relationships with its collaboration
partners and other third parties; the efficacy or safety of the
Company's products and the products of the Company's collaboration
partners; the acceptance of the Company's products and the products
of the Company's collaboration partners in the marketplace; market
competition; sales, marketing, manufacturing and distribution
requirements; greater than expected expenses; expenses relating to
litigation or strategic activities; the Company's ability to
satisfy its capital needs through increasing its revenue and
obtaining additional financing; given market conditions and other
factors, including our capital structure; our ability to continue
as a going concern; the length of time over which the Company
expects its cash and cash equivalents to be sufficient to execute
on its business plan; the impact of the current COVID-19 pandemic,
the disease caused by the SARS-CoV-2 virus, which may adversely
impact the Company's business and pre-clinical and future clinical
trials; the impact of local, regional, and national and
international economic conditions and events; and other risks
detailed from time to time in the Company's reports filed with the
Securities and Exchange Commission. The Company disclaims any
intent or obligation to update these forward-looking
statements.
Investor Relations Contact:
William WindhamVP, Solebury Strategic
CommunicationsPhone: 646-378-2946Email:
wwindham@soleburystrat.com
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